The findings were presented here on September 29th at the 22nd Congress of the European Committee for Treatment and research in Multiple Sclerosis (ECTRIMS).

"In a large sample of patients followed prospectively, we found that the risk/benefit ratio is in keeping with prior knowledge about this drug," said lead investigator Edward Fox, MD, PhD, clinical assistant professor, University of Texas Medical Branch, Austin, Texas.

Mitoxantrone is currently being evaluated for long-term safety and tolerability in patients with worsening relapsing-remitting multiple sclerosis, progressive relapsing multiple sclerosis and secondary progressive multiple sclerosis in the ongoing, multicenter, open-label Registry to Evaluate Novantrone Effects in Worsening MS (RENEW)....

The findings were presented here on September 29th at the 22nd Congress of the European Committee for Treatment and research in Multiple Sclerosis (ECTRIMS).

"In a large sample of patients followed prospectively, we found that the risk/benefit ratio is in keeping with prior knowledge about this drug," said lead investigator Edward Fox, MD, PhD, clinical assistant professor, University of Texas Medical Branch, Austin, Texas.

Mitoxantrone is currently being evaluated for long-term safety and tolerability in patients with worsening relapsing-remitting multiple sclerosis, progressive relapsing multiple sclerosis and secondary progressive multiple sclerosis in the ongoing, multicenter, open-label Registry to Evaluate Novantrone Effects in Worsening MS (RENEW)....

This risk is greatest within one month after each dose. In addition, Novantrone may cause your platelet count to go down, which increases your chance of bleeding.

Call your doctor right away if you begin to have fever, chills, sore throat, cough, pain with urination, urination more often, or if you notice any unusual bleeding or bruising.

Novantrone is dark blue in color, so it may turn your urine a blue-green color for a few days after each dose. The white part of your eyes may also have a slight blue color.

Sunday

MSF Home: LINKThe FDA has added a warning to the labeling of Novantrone that includes additional information about the potential risk of heart damage (cardiotoxicity) and a form of leukemia (secondary acute myelogenous leukemia - AML).

The new FDA labeling requires repeat testing of cardiac function prior to each dose, in addition to the baseline testing of cardiac function which was recommended by the original labeling of Novantrone.

Saturday

Heart, Leukemia Warning for MS Drug Novantrone

Heart Risks May Be Higher for Multiple Sclerosis Patients With Heart Problems

The FDA is warning doctors and multiple sclerosis (MS) patients about the risk of heart failure and leukemia from the MS drug Novantrone.

Patients may be more vulnerable if they have a history of heart disease or heart problems. Screening for heart failure should be done prior to starting treatment with Novantrone and prior to all doses administered, says the drug's maker, Serono.

Patients with heart failure should not receive Novantrone, the company says.

A Serono letter to doctors about Novantrone is posted on the FDA's web site. The letter includes a revised warning label, which has what the FDA calls "additional" and "supplemental" information about heart and leukemia risks.

About Novantrone

Novantrone is used to reduce neurological disability and/or the frequency of clinical relapses in patients with several types of MS, says Serono. Those conditions are secondary (chronic) progressive MS, progressive-relapsing MS, or worsening relapsing-remitting MS.

Novantrone is not indicated for patients with primary progressive MS, says Serono.

"Congestive heart failure, potentially fatal, may occur either during therapy with Novantrone or months to years after termination of therapy," says the revised label. It also says all patients should be carefully assessed for cardiac signs and symptoms -- such as shortness of breath, extreme fatigue with exertion, and leg swelling -- prior to the start of Novantrone therapy.

The label says heart risks may be higher in patients taking Novantrone who have current or past heart disease, those who have had (or are getting) radiation therapy to the chest, those who have previously taken cancer-fighting drugs that can affect the heart -- such as anthracyclines or anthracenediones -- and those who are also taking other drugs that could cause heart damage.